Analyte Monitoring Device and Methods of Use

• US 20110112389A1
• Filed: 01/13/2011
• Published: 05/12/2011
• Est. Priority Date: 04/30/1998
• Status: Abandoned Application

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Heller, Ephraim, Heller, Adam, Say, James, Gal, Yoram, Colman, Fredric C., Aria, Behrad, Plante, Phillip John, Vreeke, Mark S., Friedman, Keith A., Tomasco, Michael F.
• Application Number:
  US13/006,406
• Publication Number:
  US 20110112389A1
• Time in Patent Office: Days
• US Class Current: 600/347
• CPC Class Codes: A61B 2560/0252 using ambient temperature
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/1451 for interstitial fluid
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/72 Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: C12Q 1/54 : involving glucose or galactose
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: H01L 23/3107 : the device being completely enclosed
• CPC Class Codes: H01L 23/49548 : Cross section geometry H01L23/49562 takes precedence
• CPC Class Codes: H01L 2924/00 : Indexing scheme for arrangements or methods for connecting or disconnecting semiconductor or solid-state bodies as covered by H01L24/00
• CPC Class Codes: H01L 2924/0002 : Not covered by any one of groups H01L24/00, H01L24/00 and H01L2224/00
• CPC Class Codes: H01L 2924/19041 : being a capacitor
• CPC Class Codes: H01L 2924/3011 : Impedance
• CPC Class Codes: Y10S 128/903 : Radio telemetry
• CPC Class Codes: Y10T 29/49 : Method of mechanical manufacture
• CPC Class Codes: Y10T 29/49124 : On flat or curved insulated base, e.g., printed circuit, etc.

Abstract

An analyte monitor includes a sensor, a sensor control unit, and a display unit. The sensor has, for example, a substrate, a recessed channel formed in the substrate, and conductive material disposed in the recessed channel to form a working electrode. The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte. The analyte monitor may also be part of a drug delivery system to alter the level of the analyte based on the data obtained using the sensor.

Claims

1. (canceled)

2. A method for processing sensor data from a continuous analyte sensor, comprising:

receiving sensor data from a continuous analyte sensor for a first time period, wherein the sensor data comprises at least one sensor data point;

processing the at least one sensor data point to obtain a target analyte value or range of target analyte values for a future time period; and

providing output, wherein providing output comprises displaying the target analyte value or range of target analyte values on a user interface.

3. The method of claim 2, wherein the target analyte value or range of target analyte values is based on an individual physiological pattern.

4. The method of claim 2, wherein processing the at least one sensor data point to obtain a target analyte value or range of target analyte values for a future time period comprises determining whether the target analyte value or range of target analyte values is based on a clinical acceptability.

5. The method of claim 2, wherein the continuous analyte sensor is a continuous glucose sensor.

6. The method of claim 2, wherein processing the at least one sensor data point to obtain a target analyte value or range of target analyte values for a future time period comprises determining the target analyte value or range of target analyte values based at least in part on at least one parameter that is customizable by the user.

7. The method of claim 2, wherein processing the at least one sensor data point to obtain a target analyte value or range of target analyte values for a future time period comprises determining the target analyte value or range of target analyte values based at least in part on an amount and/or timing of a medicament delivery and/or caloric consumption.

8. The method of claim 2, wherein processing the at least one sensor data point to obtain a target analyte value or range of target analyte values for a future time period comprises determining the target analyte value or range of target analyte values based at least in part on a host'"'"'s physiological pattern.

9. The method of claim 2, wherein processing the at least one sensor data point to obtain a target analyte value or range of target analyte values for a future time period comprises determining the target analyte value or range of target analyte values based at least in part on the sensor data.

10. The method of claim 2, wherein processing the at least one sensor data point to obtain a target analyte value or range of target analyte values for a future time period comprises determining the target analyte value or range of target analyte values based at least in part on an analysis of the sensor data using a clinical, physiological, and/or statistical analysis.

11. The method of claim 10, wherein determining the target analyte value or range of target analyte values based at least in part on an analysis of the sensor data using a clinical, physiological, and/or statistical analysis includes determining the target analyte value or range of target analyte values based at least in part on a variation analysis of the sensor data using a clinical, physiological, and/or statistical variation analysis.

12. The method of claim 2, wherein providing output comprises displaying the target analyte value or range of target analyte values by an object representative of the target analyte value or range of target analyte values.

13. The method of claim 2, wherein providing output comprises displaying the target analyte value or range of target analyte values by a path of target analyte values.

14. The method of claim 2, wherein providing output comprises continuously, intermittently and/or selectively displaying the target analyte value or range of target analyte values.

15. The method of claim 14, wherein providing output comprises selectively displaying the target analyte value or range of target analyte values in response to a present or future clinical risk being determined.

16. The method of claim 2, wherein providing output comprises simultaneously displaying a real-time analyte value and the target analyte value or range of target analyte values on the user interface.

17. The method of claim 2, wherein processing further comprises determining a therapy recommendation to guide a user to achieve a target analyte value.

18. The method of claim 17, the therapy recommendation comprises at least one of a type of medicament and an amount of a medicament.

19. The method of claim 17, wherein providing output further comprises displaying the therapy recommendation on the user interface.

20. A system for processing sensor data from a continuous analyte sensor, the system comprising:

an input module operatively connected to a continuous analyte sensor so as to receive sensor data from the continuous analyte sensor, wherein the sensor data comprises at least one sensor data point;

a processor module that processes the at least one sensor data point to obtain a target analyte value or range of target analyte values for a future time period; and

an output module configured to display a target analyte value or range of target analyte values on a user interface.

21. The system of claim 20, wherein the target analyte value or range of target analyte values is based on an individual physiological pattern.

22. The system of claim 20, wherein the target analyte value or range of target analyte values is based on a clinically acceptability.

23. The system of claim 20, wherein the continuous analyte sensor is a continuous glucose sensor.

24. The system of claim 20, wherein the target analyte value or range of target analyte values is based at least in part on at least one parameter that is customizable by the user.

25. The system of claim 20, wherein the target analyte value or range of target analyte values is based at least in part on at least one of an amount of medicament delivery, a timing of a medicament delivery, and caloric consumption.

26. The system of claim 20, wherein the target analyte value or range of target analyte values is based at least in part on a host'"'"'s physiological pattern.

27. The system of claim 20, wherein the target analyte value or range of target analyte values is based at least in part on the sensor data.

28. The system of claim 20, wherein the target analyte value or range of target analyte values is based at least in part on an analysis of the sensor data using at least one of a clinical analysis, a physiological analysis, and a statistical analysis.

29. The system of claim 28, wherein the target analyte value or range of target analyte values is based at least in part on a variation analysis of the sensor data using at least one of a clinical analysis, a physiological analysis, and a statistical variation analysis.

30. The system of claim 20, wherein the target analyte value or range of target analyte values is represented by an object.

31. The system of claim 20, wherein the target analyte value or range of target analyte values is represented by a path of target analyte values.

32. The system of claim 20, wherein the target analyte value or range of target analyte values is displayed continuously, intermittently, and/or selectively on the user interface.

33. The system of claim 32, wherein the target analyte value or range of target analyte values is selectively displayed in response to a present or future clinical risk being determined.

34. The system of claim 20, wherein the output module is configured to simultaneously display a real-time analyte value and the target analyte value or range of target analyte values on the user interface.

35. The system of claim 20, wherein the processor module determines a therapy recommendation to guide a user to achieve a target analyte value.

36. The system of claim 35, wherein the therapy recommendation comprises at least one of a type of medicament and an amount of a medicament.

37. The system of claim 35, wherein the output module is configured to display the therapy recommendation on the user interface.